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Clinical Trials/NCT05697835
NCT05697835
Completed
Not Applicable

Behavioral Activation and Medication Optimization for Perioperative Mental Health in Orthopedic Surgery

Washington University School of Medicine1 site in 1 country116 target enrollmentFebruary 27, 2023

Overview

Phase
Not Applicable
Intervention
Behavioral activation
Conditions
Orthopedic Surgery
Sponsor
Washington University School of Medicine
Enrollment
116
Locations
1
Primary Endpoint
PHQ-ADS
Status
Completed
Last Updated
23 days ago

Overview

Brief Summary

This Hybrid 1 Study will test the effectiveness of a bundled intervention comprised of behavioral activation and medication optimization in reducing symptoms of depression and anxiety in older adults undergoing Orthopedic surgery (compared with usual care), while examining implementation outcomes.

Registry
clinicaltrials.gov
Start Date
February 27, 2023
End Date
March 19, 2025
Last Updated
23 days ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ryan Calfee, MD

Professor of Orthopaedic Surgery

Washington University School of Medicine

Eligibility Criteria

Inclusion Criteria

  • Adults ≥ 60 years
  • Scheduled primary hip or primary knee arthroplasty procedure
  • PHQ-ADS ≥ 10, indicating clinically significant depression or anxiety symptoms

Exclusion Criteria

  • Barrier to communication (Unable to read, speak, and understand English)
  • Severe cognitive impairment screened by the SBT (Short Blessed Test) \>10
  • Acutely suicidal
  • Previous participation in this study or another CPMH study of the intervention bundle or its feasibility.

Arms & Interventions

Behavioral activation and medication optimization

Behavioral activation (BA) will begin perioperatively and will span across 3 months postoperatively, with sessions approximately weekly or biweekly, depending on patient preference \& health condition. Medications will be reviewed by a team of interventionists to minimize brain-toxic medications and optimize doses of antidepressants and other mental health medications. In-hospital and after discharge, the interventionists' role will include coordinating with the care teams to ensure that medication changes that were introduced preoperatively are maintained.

Intervention: Behavioral activation

Behavioral activation and medication optimization

Behavioral activation (BA) will begin perioperatively and will span across 3 months postoperatively, with sessions approximately weekly or biweekly, depending on patient preference \& health condition. Medications will be reviewed by a team of interventionists to minimize brain-toxic medications and optimize doses of antidepressants and other mental health medications. In-hospital and after discharge, the interventionists' role will include coordinating with the care teams to ensure that medication changes that were introduced preoperatively are maintained.

Intervention: Medication optimzation

Control (treatment as usual)

Participants in control arm will continue care as usual. They will receive printed resources for supporting sleep hygiene, stress reduction, cognitive and mental health exercises, as well as community resources for older adults.

Intervention: Care as usual

Outcomes

Primary Outcomes

PHQ-ADS

Time Frame: 3 months post-operatively

PHQ-ADS (Patient Health Questionnaire Anxiety and Depression Scale) scores will be compared between the two study arms 3 months after surgery. PHQ-ADS is a composite measure of anxiety and depression. PHQ-ADS scores can range from 0 to 48 (with higher scores indicating more severe depression/anxiety)

PHQ-ADS (Patient Health Questionnaire Anxiety and Depression Scale)

Time Frame: Baseline and 3 months post-operatively

Change in PHQ-ADS (Patient Health Questionnaire Anxiety and Depression Scale) scores from baseline to 3 months postoperatively will be compared between the two study arms 3 months after surgery. PHQ-ADS is a composite measure of anxiety and depression. PHQ-ADS scores can range from 0 to 48 (with higher scores indicating more severe depression/anxiety)

Study Sites (1)

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